Physician-Initiated Research Studies

Supported by the Investigator-Sponsored Research (ISR) Program

Mission

The development of The Center for the Advancement of Research (CARE) enables Boston Scientific to support physicians' research ideas and interests by working directly with them. By supporting physician-initiated research through the ISR program, Boston Scientific can:

• Hear and address needs physicians encounter in their particular patient populations
• Recognize and benefit from the expertise of physicians to improve the science behind devices

What Does the Investigator-Sponsored Research (ISR) Program Do?

The ISR program is a conduit between Boston Scientific and external researchers. The ISR committee is a multi-functional team consisting of experts in science, clinical applications, regulatory, corporate strategy and law. These experts receive and review study proposals generated by physicians who would like to work with Boston Scientific to conduct research. The committee evaluates proposals to determine whether or not a partnership would be mutually beneficial for patients, researchers and Boston Scientific. If so, CARE will work with the sponsor-investigator to develop a research agreement and ultimately capture interesting results.

What Kind of Studies Does the ISR Program Support?

ISR program studies involve patient populations benefiting from Boston Scientific products. In most cases, the studies are fairly short in duration with expected completion and publication dates within one to two years from initiation.

Boston Scientific may sometimes identify specific areas of interest and ask physicians to submit research projects addressing those topics. However, Boston Scientific recognizes many ideas having a significant impact are generated by those who use cardiac implantable device technology everyday; they see first hand how it affects patients' lives. For this reason, the committee considers most project proposals. The ISR program is designed to review and potentially support investigator-sponsored, physician-initiated research study proposals.

How Does the ISR Process Work?

CARE maintains a website ( www.guidantcare.com ) for you to submit proposals and a web-enabled database for you to track project progress through the entire process. The interactive website enables open communication between you and ISR team members at each step along the way; from study submission and review, study progress, study completion and ultimately to publication.